Partial cuff

ABSTRACT

To increase the resistance to liquid and substance flow through a lumen of a tubular organ, a cuff comprising a flexible, mesh base member is appended to an exterior wall of the tubular organ such that it only partially surrounds the tubular organ. Ultimately, tissue ingrowth through the mesh base member integrates the cuff into the wall of the tubular organ. When the cuff is applied to the urethra of an incontinent patient, the increased resistance to flow renders the patient continent while still allowing normal voiding. The base member may also support an optional expandable component, e.g., a balloon-like element that can be selectively inflated and/or deflated to restrict the lumen of the tubular organ by a desired degree.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to Provisional application Ser. No.60/958,420, filed Jul. 6, 2007, and Provisional application Ser. No.61/011,750, filed Jan. 22, 2008, the contents of which are herebyincorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates generally to surgically implantable flowrestrictors, and more particularly to a cuff that is attachable directlyto a tubular organ for increasing the flow resistance of liquids andsubstances through the tubular organ.

2. Discussion of the Prior Art

Biological tubular organs in our body are conduits for fluids, food andwastes. For example, the urethra is the conduit for urine between thebladder and the urethral meatus and it also functions to inhibitinvoluntary leakage. In stress urinary incontinence, urine leaksinvoluntarily when the person coughs or laughs.

Stress urinary incontinence occurs most commonly in women and is managedby absorbents and by surgical interventions. Many surgeries involve theimplantation of a medical device to help decrease incontinence for thepatient. Among these implantable medical devices for women, urethralslings, in the form of a strip of material or tissue to support underthe bladder neck or mid-urethra, and with its ends anchored inanatomical locations other than the urethra or bladder, such as thepubic synthesis, and the abdominal muscles. Such slings have beenfavored by many urologists and gynecologists. The sling acts as ahammock to support and to lift the sagging urethra and/or bladder neckback to a normal position. This stops the bladder neck or urethra fromdropping during sudden movements to minimize urine leakage. The newergeneration of slings generally is implanted in one of three approaches.It is approached from the below, Ulmsten, U.S. Pat. No. 6,491,703 (thevaginal approach); from on top, Staskin et al. U.S. Pat. No. 6,612,977(the suprapubic approach); and from below and goes laterally to the twosides (the transobturator approach, Monarc Subfascial Hammock fromAmerican Medical Systems). All three approaches involve the use of longrods passing blindly from one anatomical site to the other, and oftenresulting in puncturing of the bladder and/or blood vessels. Though thetransobturator approach avoids the retropubic space and does not lead topuncturing of the bladder, it suffers as the other two in that itinvolves anatomical structures outside of the urinary tract system andthus, typically, not familiar to urological surgeons. In addition, aprecise adjustment of the sling tension for each patient is notpossible. This ill adjustment results in lower than expected level ofefficacy and complications including urethral erosions. Furthermore, asthe sling is being anchored in anatomical structures other than theurethra, it presents complications, such as injuries to bladder, bloodvessels, nerves and muscles and is contraindicated for women patientswho intend to have child births in the future.

For extreme cases, an artificial urinary sphincter (AUS) is implantedfor the incontinence where a band, similar to a blood-pressure cuff,fully surrounds the urethra. Fluid is made to enter the band andconstantly exerts compression to the urethra to occlude the urethrallumen. The patient needs to actively pump the fluid out of the band andinto a balloon reservoir implanted in the abdominal area every time thepatient needs to void. The AUS is a complex system and the associatedsurgical procedure is major, complex and long. Buuck, in U.S. Pat. No.3,863,622 (1975), Burton, in U.S. Pat. No. 4,222,377 (1980) and Polyak,in U.S. Pat. No. 4,994,020 (1991) described an artificial sphincter(AUS) system that is a totally occlusive device having an inflatableband completely surrounding the patient's urethra. The urethra isessentially occluded continuously and constantly until the fluid in theband is actively pumped out by the patient at the time when he or shedesires to urinate. Once the fluid is pumped out the AUS band, thecompression surrounding the urethra is diminished and the urethral lumenfor passage of urine can then open. With the AUS, patients cannoturinate without first having to actively manipulate the device to pumpthe fluid out of the band and into a reservoir at a distant location toremove the urethral occlusion.

Urethra is only one of the many biological tubes in the body. Otherbiological tubular organs include the esophagus, stomach, colon, bloodvessels and the heart. All these tubes can suffer from defects and losetheir intended function in controlling flow of material and fluidswithin them.

Broadly speaking, the present invention comprises a cuff that onlypartially surrounds an anatomical tubular organ, such as the urethra.Many biological soft tissue tubes are expandable in girth to accommodatepassage of material through their lumen. The muscle components in thewall of the tube provide tonicity and elasticity. For example, thestomach expands as food enters, the esophagus opens up to allow food topass down, the lower esophageal sphincter or the cardiac sphincter opensto allow passage of food but closes to prevent regurgitation of foodmaterial and stomach acid up the esophagus, intestines expand toaccommodate food material and provides peristaltic action to propagatethe food material down its length, and the urethra expands to allowurine to flow through. After the material has exited, the diameter ofthe tubular organ again retracts to its non-expanded size. Theattachment of a partial cuff, made of non-elastic or limited elasticitymaterial, and that only partially surrounds the tubular organ, willlimit the expansion of the portion of the tubular organ covered by thecuff, allowing only the non-covered portion to expand. For material topass through this juncture with the reduced expandable wall tissue, ahigher force is required to open the passage way. The reduced amount ofexpandable tissue at the site of the partial cuff results in a highertissue tension that would require a higher force in order to push thesame amount of material through this juncture. If the cuff has been madeto completely surround the tubular organ with a closed lumen, thenlittle or no material will be able to pass through this juncture.However, when the cuff only partially surrounds the tubular organ, theportion that is not restrained by the cuff will still be able to expand,allowing passage of material. The lesser amount of tissue allowed toexpand results in either a higher pressure to open the lumen to the samesize or allowing only a smaller lumen to be opened due to limits ontissue stretch, or both. The partial cuff of the current inventioninduces an increased tonicity to the biological tubular organ. This isone of the unique and non-obvious principles of the invention, providinga means to increase material passage resistance in a biological softtissue tube while still maintaining the profile of the biological tube.

When used in treating stress urinary incontinence, the partial cuff ofthe present invention does not occlude the urethra, but only addreinforcement to maintain the urethral closure pressure. Benefits ofsuch a partial cuff include improving continence and allowing patientsto void naturally and volitionally. This augmentation of a higherurethral tonicity for closure means an increased resistance to urineflow in stress situations such as when the patient laughs and coughs. Asthe cuff becomes an integral portion of and moves with the urethra, itsability to provide continence is not affected by the physical positionthe patient happens to be in or gravity. Because the partial cuffattaches to only the urethra and is not tied to other tissues and bones,the present invention also avoids many of the possible adverse events,contraindications and pitfalls with the traditional slings. As itinvolves only the urinary tract anatomy, urological surgeons will haveintimate knowledge of the operating field and its surgical implantationwill not involve long rods passing blindly through various anatomicalstructures.

SUMMARY OF THE INVENTION

The invention, an improved surgical device and method to treat urinaryincontinence, has a cuff with a flexible base member that only partiallysurrounds the urethra. The partial cuff does not occlude the urethra.The cuff may, but need not, incorporate an adjustable, expandable ordeflatable component that applies pressure on one side of the urethra,allowing accurate adjustment to achieve desired coaptation whileallowing the patient to void naturally and normally. The similarprinciple applies to other biological tubular organs such as the ureter,anal sphincter, stomach, esophagus, heart, etc. Hence, the inventionwill also treat other conditions where a flow of material needs to bemodulated in a biological tube.

The invention provides a simple, minimally invasive surgical procedure.It allows adjustments after surgery and after tissues have healed byproviding positive pressure to achieve the right amount coaptationneeded by the patients condition. The invention allows natural andvolitional voiding for incontinent patients.

DESCRIPTION OF THE DRAWINGS

FIG. 1a is a top plan view of a first embodiment of the presentinvention;

FIG. 1b is a side elevation of the embodiment of FIG. 1 a;

FIG. 2 is a top plan view of an alternative embodiment;

FIG. 3a shows an embodiment like that of FIG. 1 but with an inflationport feature added to it;

FIG. 3b is a side elevation of the embodiment of FIG. 3 a;

FIG. 4 is a top plan view of a further embodiment of the invention;

FIG. 5a is a cross-sectional view showing the preferred embodimentcoapted to a tubular organ and with the inflatable component deflated;

FIG. 5b shows the embodiment of the present invention coapted to atubular organ and with the inflation component inflated;

FIG. 6a is a perspective view of the cuff affixed to a tubular organwith its expandable component deflated;

FIG. 6b is a view like that of FIG. 6a but with the expandable componentinflated;

FIG. 7a shows the cuff of the present invention disposed on a tubularurethra proximate the bladder neck and with the expandable componentdeflated;

FIG. 7b is a view like that of FIG. 7a but with the expandable componentinflated;

FIGS. 8a through 8e illustrate the manner in which a specially designedtool can be used to secure the cuff of the present invention to theexterior wall of a tubular organ;

FIG. 9 illustrates an attachment hook assembly;

FIG. 10 illustrates the hook assembly of FIG. 9 affixed to a cuffmember; and

FIG. 11 illustrates a further embodiment of the invention;

FIG. 12 shows the further embodiment of FIG. 11 affixed to a tubularorgan;

FIG. 13 is yet another alternative embodiment;

FIG. 14 shows the embodiment of FIG. 13 affixed to a tubular organ; and

FIG. 15 shows a mesh material affixed to a C-shaped wire frame.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1a and 1b of the drawings, the partial cuff 11,comprising a first embodiment, is seen to include a flexible base member12 that is preferably a synthetic mesh-like fabric formed frompolypropylene strands like those used in surgical repair of hernias andurethral slings. That type of mesh is bio-compatible and accommodatestissue ingrowth through the interstices of the mesh material.

Without limitation, the mesh base member 12 may be generally oval orelongated in shape having a major axis measuring about 3 cms and a minoraxis of about 1½ cms when the device is to be used in addressing femaleurinary incontinence.

In accordance with a first aspect of the invention, there is affixed tothe flexible, mesh base member 12 an expandable component 13 having apredetermined shape configuration and generally centrally disposed onone major surface of the flexible base member 12. The expandablecomponent 13 may comprise an elastomeric balloon capable of beinginflated and deflated by an isotomic inflation fluid injected andremoved through a suitable injection port.

As shown in FIG. 2, the expandable component may comprise a pair ofclosely-spaced balloon segments 15 a and 15 b joined together by atubular pathway 16. When inflated, the expandable component forms a pairof ridges that are made to press upon the urethra for increasing theflow resistance thereof.

The expandable components 13 in FIGS. 1a and 15 in FIG. 2 have theirlength dimension generally perpendicular to a guide line 14 that isvisible to a surgeon and that is useful in appropriately aligning thecuff with respect to the patients urethra.

Turning next to FIG. 3a , it illustrates an inflation/deflation port 17leading to the interior of the expandable component 13. In FIGS. 3a and3b , the inflation port is illustrated as comprising a tube 17 thatincludes a purse-string suture thereabout (or a one-way valve or aself-sealing end) that can be used to seal the tube 17 once an inflationfluid, such as saline, has been fed through it to inflate the expandablecomponent 13 to a desired state to thereby maintain the expandablecomponent in its inflated condition.

Rather than utilizing a tube 17 as the inflation port, it is alsocontemplated that the expandable component 13 include a pad area of aself-sealing elastomeric material that is adapted to be punctured by ahypodermic needle affixed to an inflation syringe. The material of theinflation port is such that when the needle is removed, the openingself-seals to preclude leaking out of the inflation fluid.

An alternative method for adjusting the pressure applied is to deflatethe balloon(s) that has been pre-inflated with saline prior toimplantation. Once the mesh is fully integrated with the tissue, thepatient will come into the clinic for this post-surgical adjustment. Inthis case, the physician will let out a certain amount of saline (bypuncturing the balloon's inflation port with a needle) till a desiredlevel of compression is achieved. If there are separate balloons, thenthe deflation process is dependent on the judgment of the physician, ashe may let the saline out totally in one balloon and observe its effect.If more relief is needed, he can partially empty another balloon. Theendpoint will be determined with clinical observation regarding whetherthe patient can void without difficulties and does not leak duringValsalva's maneuver, coughing, etc. Deflation is deemed necessary whenthe patient is obstructed, which means he or she has difficulty voiding.Deflating the balloon or balloons will decrease the compression on theurethra, hence the urethral lumen opening, to allow urine to passthrough during natural voiding.

Another possible method of pos-surgical adjustment is via heat, such asthat induced by RF energy. From the weave of the mesh, the material fromwhich it is formed or a special material integrated with the mesh, atleast a portion of the mesh can be made to shrink due to the externallyapplied heat, thus making the cuff tighter on the urethra. Again, thiscan be done in stages for fine tuning the effect once tissue ingrowthinto the mesh base member has occurred.

Also seen in FIG. 3b is a plurality of tissue piercing hooks 27 that isaffixed to the base member 12 surrounding its periphery. When thepartial cuff of the present invention is applied to a tubular organ,such as a subject's urethra, in a manner hereinafter described, thehooks are adapted to penetrate into the wall of the urethra and therebyhold the cuff in partial surrounding relation to the exterior urethralwall as shown in FIGS. 5 through 7 of the drawings.

The hooks 27 are preferably formed from a biodegradable material thatwill serve their purpose of adhering the cuff to the outer wall of theurethra for a time sufficient to permit tissue ingrowth in the mesh basemember.

With reference to FIG. 5a , the tubular organ 19 is shown incross-section with the cuff 11 of the present invention surroundingapproximately one-half of the circumference thereof. In this view, theexpandable component 13 is shown as being deflated and with the tissuetubular lumen 20 in an open state, which it could be in an incontinentsubject. If the tubular tissue represents a urethra, that wouldrepresent a patient with severe incontinence or a patient with a “stovepipe” urethra, as normally, the urethra is devoid of an open lumen atrest. A lumen only exists when urine passes through it. The base member12 of the cuff is held in intimate contact with the exterior wall of thetubular organ, e.g. the urethra, by means of the aforementioned hooks 27and ultimately tissue ingrowth.

FIG. 5b is a view like that of FIG. 5a , except with the expandablecomponent 13 in its inflated state. As seen in this figure, theexpandable component 13 pushes itself against the tubular wall to narrowor close the lumen 20 and at least increasing the resistance to fluid orother material flow therethrough.

In accordance with the present invention, by controlling the extent ofinflation of the expandable component by either injecting an inflationfluid into a flaccid balloon or withdrawing fluid from a turgid balloon,the degree of closure and, hence, the resistance to fluid flowtherethrough can be adjusted to the point where the tubular sphincter iscapable of fully collapsing the tubular lumen and thereby keeps thesubject in a dry condition such as in the case of an incontinentpatient.

Those skilled in the art appreciate that the tubular organ urethra isnormally without an open lumen. A lumen only exists when urine ispassing through it. This means that the musculature of the urethralwall, including the sphincter muscles, are normally contracted to thekeep the lumen closed, thereby preventing unwanted passage of urine,i.e., incontinence. This musculature relaxes during normal micturition.The brain sends signals to the muscles of the bladder wall, thedeturusor muscle, to contract and, at the same time, to the sphinctermuscles, including those muscles of the urethral wall to relax. In thisway, urine is forced out of the bladder and flows down the now-relaxedurethral tube and exits the body.

Since muscles and tissues consist of mostly water, their volume isessentially not compressible. The closed urethral tube, made of tissue,can be measured to have a certain diameter. As urine creates apassageway down this tube, the diameter of this passageway, because ofthe non-compressible tissue mass, will be translated into an increasedcircumference of the urethra, exhibiting an overall increased diameterand a thinner wall. Another way to express this is that the urethralwall will be stretched to accommodate this passageway created by theurine.

The urethral wall, containing the contracted muscle, can be compared toa circular rubber band. The urine, in creating the passageway,represents a force stretching the rubber band. As an example, if thediameter of the urine passageway translates to 5 mm, this 5 mm would,therefore, be distributed into the entire cross-section of the urethra.Each segment of the urethral wall and its muscles will be stretched anapportioned length for an aggregate total of 5 mm. If one were toartificially create a situation where the cross-sectional half of theurethral wall is restricted from becoming stretched, then the other halfwill have to be stretched twice as much to allow the same amount of thetotal required expansion of 5 mm.

The contracted musculature is analogous to that of a rubber band.Stretching will require a force. If a 15 mm long rubber band isstretched to be 20 mm long, a certain amount of force will be needed. Ifonly half of the 15 mm rubber band is allowed to stretch, then theamount of force to stretch the 5 additional mm will be greater with the7.5 mm rubber band. Similarly, a partially restricted urethral wall willrequire a greater force to open than if the urethral wall were notpartially surrounded by the cuff. It is this added force that isrequired to stretch a shortened band that forms one of the underlyingprincipals of the present invention. If a portion of the urethra isrestricted from stretching or expanding, then it will take more force tostretch the remainder of the urethra to achieve the same opening size.

As shown in FIGS. 5a, 5b, 6a and 6b , the cuff 11 restricts only aportion of the urethral wall from stretching. The unrestricted portioncan still be stretched, albeit requiring more force to do so. In stressurinary incontinence, urine is forced down the urethra as the bladder isbeing suddenly compressed by abdominal muscle during coughing, laughingand other common daily activities. In these patients, the urethralmusculature is insufficient to maintain closure, such that it lets someurine to pass through during this sudden increase in pressure on thebladder. The amount of leakage varies from patient to patient,paralleling the degree of weakness of the musculature. Analogoussituations occur in fecal incontinent and acid reflux.

During normal micturition, the urethral musculature relaxes and theurethral lumen will open to allow the passage of urine freely down thepath. The harder the bladder squeezes, the more urine will rush out ofthe bladder and down the urethra, thus a faster flow rate. This fasterflow rate translates to a thicker urine stream, reflecting a widerurethral lumen.

If a restriction were to be put completely around the urethra, such thatnone of the urethral wall under the restriction is allowed to bestretched, then no passage lumen can be created in the urethra and nourine can flow through it. This is somewhat analogous to males with asevere case of benign prostatic hyperplasia (BPH) in that the enlargedprostate gland impinges on the urethra and the patient is in retention,or unable to void.

In the practice of the present invention, the novel and non-obviousprinciple of only applying a partial restriction to stretching orexpansion of the urethra results in an increased resistance to flow thatwill benefit most of the stress urinary incontinent patients, and yetwhen these patients want to void, the unrestricted portion of theurethral wall can relax automatically, via normal and natural neuralsignaling, allowing urine to flow through as any normal micturition.

FIG. 7a is a sagittal view taken laterally through the bladder, bladderneck and urethra of a woman. Here, the partial cuff 11 of the presentinvention is adhered to the urethra at a location proximal to theurinary sphincter. Again, the cuff 11 is shown as only partiallysurrounding the urethra 22 and when the inflatable component 13 is inits deflated condition (FIG. 7a ), the lumen 23 is unrestricted. Byinjecting a suitable inflation fluid into the interior of the expandablecomponent or balloon 13, the urethral wall is displaced in a directionto at least partially occlude and increase the resistance to flow of thelumen 23. In accordance with the invention, however, the expandablecomponent 13 is only expanded to the point where, at rest, urine flowthrough the urethra is blocked. However, when the signals from the brainresult in contraction of the bladder wall, the resulting increase influid pressure will allow the urethra muscles to relax and expandsufficiently so that the lumen will open and normal voiding may takeplace.

In order to apply the cuff of the present invention to the urethralwall, a special tool shown in FIG. 8a may be used. It is seen tocomprise a pair of handles 24 having opposed jaws 25 on one end thereofand where a hinge pin or rivet 28 allows the jaws to open and closerelative to one another upon appropriate manipulation of the handles 24.The jaws include a plurality of raised projections, as at 26, that aredesigned to cooperate with the hooks 27 on the flexible base member ofthe cuffs 11 to cause them to impinge into the outer urethral wall whenthe jaws are made to close relative to one another about the tubularorgan being addressed.

FIG. 8b illustrates the tool of FIG. 8a with a cuff of the presentinvention positioned between the jaws 25 of the tool just prior to use.The optional expandable component or balloon 13 is centrally disposed.The surgeon will align the index mark or guide line 14 with a length ofthe urethra as shown in FIG. 5c , and now, when the handles are squeezedtogether, the jaws 25 will close with the urethra cradled therein. SeeFIG. 8d . The projections 26 on the tool jaws are designed to cooperatewith the hooks 27 on the base member 12 to thereby cause the hooks topierce into the urethral wall as shown in FIG. 8e and thereby hold thecuff in partially surrounding relation relative to the circumference ofthe urethra. After a period of time, measured typically in weeks, tissueingrowth will have occurred, thereby embedding the cuff 11 into theurethral wall and restricting expansion of the urethral wall in the areaoccupied by the cuff. As earlier described, this increases the flowresistance of the urethra without totally causing occlusion and therebyallowing normal micturition while inhibiting unwanted urine flow fromthe increases in bladder pressure due to laughing, sneezing, coughing,etc.

In accordance with another aspect of the invention, the cuff maycomprise a flexible mesh base member having an expandable componentaffixed to one major surface of the base member. The cuff will increasethe urethral resistance of urine flow by creating a direct andadjustable coaptation in the urethra, but not occluding it. Theexpandable component is situated on one side of the urethra between theurethral wall and the cuffs base member. As the expandable componentinflates, it forces the urethral wall inward as the other side of theexpandable member is confined by the cuffs inelastic base member. Thisresults in an inward indentation of the urethral wall, resulting innarrowing of the urethral lumen, leading to an increased coaptation andresistance to urine flow and decreased incontinence.

As the cuff is attached only to the urethra and not to surroundinganatomical structures, the pressure produced by the expandable componentwill remain the same regardless of the urethral movements. This is acritical, non-obvious difference between the present invention and thetraditional urinary bladder support slings. Also, because the cuff isattached only to the urethra, the amount of coaptation can be adjusted,tailoring to the need of the patient's incontinence condition.

In contrast to the Artificial Urinary Sphincter (AUS) previouslydescribed, the present invention is a partial cuff. The presentinvention will not constrain the segment of the urethra opposite thecuff from relaxation and expanding during normal urination, and urinecan, therefore, flow naturally past the cuffed region. The patient doesnot have to actively manipulate a pump mechanism to open the urethrallumen for micturition to occur. Therefore, with the present invention,as opposed to the AUS, patients will be able to micturate normally andnaturally without any abnormal manipulation.

Though the invention will be used mostly for women, as incontinence ismore pervasive in women, it is also applicable for men's incontinencecondition, such as may result in post-prostatectomy situations and incertain post transurethral resection of the prostate situations.

In certain instances, the expandable component on the base member doesnot need to be expanded, as the act of surgery and its resultant scarformation would provide sufficient compression to the urethra to achievecontinence.

A first preferred embodiment of the invention is a cuff that onlypartially surrounds the urethra or other tubular organ through whichflow is to be resisted.

A second preferred embodiment of the invention comprises a cuff composedof a base member and an expandable component on the base member. Aportion of the base member can be firmer than the rest of the basemember. The partial cuff is adapted to be attached to the urethra withthe expandable component facing the urethra.

The expandable component is preferably an inflatable, expansibleballoon. The inflation and deflation of the balloon can be done througha port, such as a tube, that can be permanently attached to ordetachable from the balloon. The other end of the tube preferably has aself-sealable end for injection or withdrawal of the inflation materialduring the adjustment of the size of the balloon suitable for thepatient's condition. The inflation port may also be a self-sealing patchon the cuff. This patch can be felt through the skin or seennon-invasively via other means for convenient identification by thephysician doing the balloon sizing. The self-sealing material of thepatch permits piercing by an injection needle without leaking when theneedle is removed.

The fixation of the device to the urethra is accomplished by firstfastening the base member to the urethral wall and/or biological tissue,followed by tissue ingrowths into the material of the base member overseveral weeks post surgery.

For example, the base member material is preferably, but notnecessarily, a mesh-like synthetic fabric having fringes extending atleast beyond the two ends of the balloon and these fringes provide easystitching or fastening to the urethra by the surgeons and the meshfabric will allow tissue ingrowths to further naturally and firmlysecure the attachment of the cuff to the wall of the involved tubularorgan.

The mesh-like fringe can extend along the entire perimeter of the cuff.The fringe area can be substantially larger than the expandablecomponent. A preferred shape of the cuff may be rectangular, but withrounded ends.

The fastening of the cuff to the tubular organ can be accomplished bysutures or by small hook-like elements placed on the cuff or by asuitable adhesive, such as tissue glue, albumin and glutaraldehydetissue adhesives or polyethylene glycol polymers. The hook-like elementsare placed on the same side of the cuff as the expandable component.These hook-like elements fasten the base material to the wall tissue ofthe anatomical tube, such as the urethral wall tissue, to hold the cuffin place while tissue ingrowths is taking place. Once tissue ingrowthsis complete, the cuff becomes integrated into the wall of the tubularorgan and these hook elements will no longer be necessary. They candissolve and be absorbed by the body.

The hook-like elements can be pre-affixed onto the base member of thecuff or applied by the surgeon at the time of implant.

As a further feature, a combination of two types of hook-like elementscan be utilized as fasteners. The pre-affixed hook-like elements on themesh base member serve as a fast general attachment of the cuff and thensupplemented by placement of additional hook-like elements to refine thecuff attachment to the tissue. The use of tissue glue or tissue adhesivemay also be used to supplement the hook-like elements.

The hook-like elements are preferably made of a biocompatible andbio-resorbable or degradable material known in the art. The hook-likeelements eliminate the need for surgeons to suture the cuff to theurethra. With these hooks, the cuff may be applied to the urethra with asimple tool. For example, a forceps-like tool can be used to apply thecuff to the urethra. Its jaws can be suitably shaped to accommodate thecurvature of the tubular organ.

The hooks can be pre-assembled onto the cuff. As already described inconnection with FIGS. 5a-8e , two curved forceps jaws, each capturing anend of the cuff, can be used to push the cuff towards and place itagainst the tubular organ, e.g., the urethra, to partially surround it.Once in place, the handles of the tool are manipulated to set the hookson the cuff into the wall of the tubular organ from outside in.

The tool embodies a means to hold onto the cuff before deployment of thecuff onto the tissue. Once the cuff is in place and its hooks areembedded into the tissue, the tool can be withdrawn, releasing the cuffand leaving it attached to the tissue.

The means employed to cause the tool's jaws to hold onto the cuff may besmall pin-like or hook-like protrusions 26 disposed at an angle on theinside curves of the jaws. These protrusions prevent the cuff 12 fromfalling off while it is being pushed forward along and against the wallof the tubular organ, as the action of pushing forward forces the cuffto be tightly engaged to the forward pointing protrusions 26. However,after the cuff is fastened onto the tissue wall of the tube, by pullingback the tool, it releases the cuff 12 as these protrusions are nowpointing rearward as compared to the movement of the tool jaws.Similarly, but with an opposite intent, the hook-like elements 27 on thecuff will have the hooks pointing rearwards as the cuff is pushedforward by the tool, so that once they are engaged into the tissue, thehook-like elements prevent the cuff from sliding back and off of thetubular organ, e.g. a urethra.

Among different ways of having the hooks preassembled onto the cuff, asin FIG. 3b , an embodiment of a hook assembly like that shown in FIG. 9may be utilized in a manner illustrated in FIG. 10. FIG. 9 illustratesan example of a hook assembly 29 to be used for attachment of the cuff'sbase member to the exterior wall surface of a biological tube. The hookassembly may consist of a plurality of hooks 32 that are joined by apair of connectors 30 and 31 where hooks 32 serve to engage the tissueof the biological tube and the hooks 333 serve to engage the base member12 of the cuff 11. The connectors 30 and 31 serve to space the hooks indesired locations on the cuff and provide even tension for maintainingthe shape of the cuff during attachment to the biological tube. Theconnectors 30 and 31 can also provide an easy way for reversiblyengaging and disengaging the deployment tool. Furthermore, the locationof the connector 30 can be situated in a position proximate to the hooks32 such that it will assist in the deployment handle of the tool pushingdown on the hooks 32 in engaging the tissue of the biological tube.Different hook numbers and connectors on the hook assembly can beapplied to fit the needs of the particular cuff application. For largercuffs, one or more of sets of the hooks can be utilized. FIG. 10illustrates one possible placement of the hook assemblies 29 on theopposed ends of the cuff 11.

The expandable component on the partial cuff can be inflated preciselyto achieve the degree of urine flow resistance desired. This is feasibleas the adjustment can be carried out a few weeks after the surgery at atime when tissues have healed and inflammation has subsided, thereforeallowing more meaningful and accurate adjustment of the urethralcoaptation.

As already indicated, the expandable component can be an inflatableballoon with different shape configurations. The expandable componentcan have different forms, e.g., it could be a single balloon as in FIG.1, a set of two or more narrow balloons as in FIG. 2, resembling ridges,on the base member. These ridges will preferably be applied to theurethra such that they extend across the urethra, perpendicular to theurine flow pathway. These ridges can also be applied to the urethra suchthat they are inline with the urethra, parallel to the urine flowpathway creating a longer compression zone. These ridges can also bebilateral on opposite sides of the urethra.

In accordance with a further embodiment, the ridges can also bepreformed so that no inflation would be needed. The preformed ridges canbe made of silicone rubber or other biocompatible material and there canbe open spaces between the pair of ridges.

The material of the base member as well as the inflatable balloon may bemade of flexible, biocompatible material, such as silicone rubber. Thebase member can be made of polypropylene or polyethylene strands ormeshes similar to those used in hernia repairs of general surgery andslings of urological surgery.

Additional mechanisms, such as ports and tubes, can be added to make theexpandable component of the cuff inflatable and deflatable for futureadjustments as the patient's condition changes. The inflation anddeflation port can be placed in locations that it can be used in thefuture without surgery.

Rather than comprising a balloon, the expandable member may comprise asmall pouch of moisture permeable material, such as a silicon rubbermembrane, micro-porous Teflon membrane or a regenerated cellulosemembrane, where the pouch contains a hydrophilic material, such asagarose particles, polyacrylamide particles or serum albumin and thatexpands on the absorption of moisture.

A midline marking 14 can be applied to the bottom of the base member toassist the surgeon in aligning the device over the urethra or othertubular organs. Surgically, the cuff can be implanted trans-vaginally,via a single midline incision or a flap at the anterior wall of thevagina in incontinent women patients. To make the surgery easier and asearlier presented, the cuff can be deployed by a deployment tool thatholds the cuff for attachment to the outside of the tubular organ andreleases the cuff after the cuff is engaged into the tissue.

In a still further alternative embodiment, the cuff may comprise aC-shaped clip formed from a resilient medical-grade plastic or abiocompatible metal rather than a synthetic mesh and that is designed topartially surround a tubular organ, e.g., the urethra. The clip isdesigned to span an arc greater than 180° but less than 360° andpreferably a range from about 235° to 300° and the effective diameter ofwhich creates somewhat of an interference fit with the tubular organthat is made to surround.

Referring to FIG. 11, a first type of C-clip is illustrated andidentified by reference numeral 34. FIG. 12 shows the C-clip 34 whenclamped onto a tubular organ 36. The presence of the C-clip preventsexpansion of the tubular organ 36 subtended by the clip and, inaccordance with the present invention, increases the resistance to flowthrough the lumen 38 of the tubular organ.

While the C-clip shown in FIGS. 11 and 12 comprise a continuous metal orplastic arcuate strip, the clip may also be fenestrated, such as bylaser cutting, to facilitate tissue ingrowth therethrough andintegration with the vessel wall.

FIG. 13 shows a C-band 40 comprising a metal or plastic wire or strandthat exhibits resiliency, allowing it to be spread for placement about atubular organ, but when released, closes about the tubular organ asshown in FIG. 14. Rather than simply using a single C-band 40, pluralsuch bands may be placed about the tubular organ in a closely spacedrelationship so as to create a desired degree of compression on thetubular organ and, therefore, greater resistance to flow through thelumen 38 thereof. It is also contemplated that one or more C-bands 40can be applied over a soft, partial mesh cuff like that shown in FIG. 1bto hold it in place on the tubular organ while tissue ingrowth occurs.When so used, the C-bands can be made of bio-resorbable orbio-degradable material.

FIG. 15 shows yet another way of implementing the partial banding of afluid carrying tubular organ to increase its resistance to flow. Here, apolypropylene mesh strip 42 is supported by a frame member 44 formedfrom a suitable metal or plastic exhibiting a memory property whenstressed below its elastic limit and then released. Without limitation,the frame may comprise a nitinol wire that has been heat treated in amold to form the C-shape configuration illustrated in FIG. 15. When theband is spread, placed about a tubular organ and then released, the meshstrip is brought into intimate engagement with the tubular organ andover a few-week period becomes endothelialized, thus reinforcing theorgan wall at the placement site.

The cuff is suitable for treating females with stress incontinence. Thecuff is also suitable for men with incontinence, such as may occur afterradical prostatectomy, other procedures or in conditions where anincreased resistance to urine flow would be beneficial in controllingincontinence.

The cuff of the present invention may find other uses. It can besuitable to treat ureteral reflux or to minimize food regurgitation orreflux into the esophagus, limit the food intake into the stomach, andstrengthen the ventricular wall of the hypertrophied heart and bloodvessels. It is also contemplated that the partial cuff of the presentinvention can be used to minimize fecal incontinence. In fact, thepartial cuff may be suitable for treating conditions where material ispassed in an anatomical tube in which the flow of material needs to bemodulated.

This invention has been described herein in considerable detail in orderto comply with the patent statutes and to provide those skilled in theart with the information needed to apply the novel principles and toconstruct and use such specialized components as are required. However,it is to be understood that the invention can be carried out byspecifically different equipment and devices, and that variousmodifications, both as to the equipment and operating procedures, can beaccomplished without departing from the scope of the invention itself.

What is claimed is:
 1. A surgically implantable cuff comprising: a basemember having a length terminating at first and second ends, the basemember including a biocompatible material having openings therethroughconfigured and arranged to facilitate tissue in-growth into at least aportion of the biocompatible material when the cuff is secured to anouter wall of a tubular body organ; the base member having a lengthbetween the first and second ends dimensioned to span a limitedcircumferential portion of said outer wall over an arc greater than 180°and less than about 310°, and including a shape-memory alloy configuredand arranged with structural rigidity between the first and second endssufficient to passively limit flow of material through a lumen of thetubular body organ, when the first and second ends are terminated on thetubular body organ, by decreasing elasticity of the outer wall of thetubular body organ via the tissue in-growth and thereby increasingtonicity of said outer wall of the tubular body organ; and an expandablecomponent attached to the base member between the first and second endsand on one side thereof, the expandable component comprising aninflatable balloon or a pouch containing material that expands withabsorption of fluids.
 2. The cuff as in claim 1, wherein the expandablecomponent is attached to the base member between the first and secondends and on one side thereof, and is smaller in size than the basemember.
 3. The cuff as in claim 1 wherein the balloon is a tubularballoon.
 4. The cuff as in claim 1 wherein the expandable component issmaller in size than the base member.
 5. The cuff as in claim 1 whereinthe expandable component, when inflated, provides a desired amount ofindentation to the tubular organ for effecting a desired coaptation ofthe outer wall of the tubular body organ.
 6. The cuff as in claim 1wherein the balloon has a port for injecting and removing an inflationfluid into and from the balloon.
 7. The cuff as in claim 6 wherein theport is a tube connecting to the inside of the balloon and adapted toextend to another anatomical location for improved access.
 8. The cuffas in claim 6 wherein the port is a patch on the base member and theballoon, the patch being made of a self-sealing material that allowsinsertion of a needle for injecting and removing the inflation fluid forthe balloon.
 9. The cuff as in claim 8 wherein the patch is palpablethrough skin of a patient in which the body organ resides.
 10. The cuffas in claim 6 wherein the inflation fluid is an isotonic solution. 11.The cuff as in claim 1 wherein the pouch is made of a material that ispermeable to fluids.
 12. The cuff as in claim 1 and further includinghook elements on the base member for adhering the cuff to a wall of thetubular body organ, wherein the base member is configured and arrangedto decrease the elasticity of the outer wall of the tubular body organexclusively via internal structural rigidity of the shape-memory alloywith ends of the base member terminating on the wall of the tubular bodyorgan, and without translating any external force to the base member.13. The cuff as in claim 1 wherein the tubular body organ is selectedfrom a group consisting of a urethra, ureter, esophagus, rectum,stomach, heart and blood vessel and the shape-memory alloy is configuredand arranged to decrease the elasticity and passively limit the flow ofmaterial without coupling of the cuff to any structural componentextending beyond the first and second ends.
 14. A method for impartingstrength or tonicity to a soft tissue tubular organ comprising fasteningand fixation of a cuff of claim 1 on the tubular body organ.
 15. Amethod for imparting strength and tonicity to a soft tissue tubularorgan comprising fastening and fixation of the cuff of claim 1 on thetubular body organ with the expandable component facing the tubularorgan.
 16. A method for imparting strength and tonicity to a soft tissuetubular anatomical organ comprising: (a) fastening of the cuff of claim12 on the tubular anatomical organ with a deployment tool system havingjaw members adapting to a geometric surface of the tubular anatomicalorgan.
 17. A method for imparting strength and tonicity of a soft tissuetubular anatomical organ comprising: (a) fastening of the cuff of claim1 with the expandable component on one side of the tubular organ; and(b) inflating the expandable component inwardly toward the tubular organto cause its lumen to achieve desired coaptation for an increase inmaterial flow resistance following biological tissue in-growth into thecuff.
 18. The method as in claim 17 wherein the step (b) takes placeafter surgical trauma to the tubular organ and surrounding tissue havesubsided and that the cuff is well affixed to the outside of the tubularorgan through tissue in-growth into the cuff.
 19. The method as in claim17 wherein the tubular organ is a female patient's urethra.
 20. The cuffof claim 1, wherein the biocompatible material comprises a flexible meshthat is perforated to facilitate the tissue in-growth.
 21. The cuff asin either of claim 1 or 20 wherein the first and second ends arerounded, and the base member is configured and arranged to passivelylimit the flow while the base member is not coupled to any externalstructure.
 22. The cuff as in either of claim 1 or 20 and furtherincluding a plurality of hooks secured to the base member for affixingthe cuff to the tubular organ.
 23. The cuff as in claim 22 wherein thehooks are bioresorbable.
 24. The cuff as in either claim 1 or 20 whereinthe cuff is adapted to be affixed to the tubular organ with abiocompatible adhesive.
 25. The cuff as in either claim 1 or 20 whereinthe cuff is adapted to be affixed to the tubular organ with at least onegenerally C-shaped clip, and wherein the shape-memory alloy exhibits amemory property, when stressed below its elastic limit and thenreleased.
 26. A method for imparting strength and tonicity to a softtissue tubular anatomical organ comprising: fastening the cuff of claim1 onto the outer wall of the tubular organ; waiting a sufficient timefor tissue in-growth to occur; and subsequently applying sufficient heatenergy to the base member to effect shrinkage of the base member. 27.The cuff as in claim 1, wherein the base member exhibits structuralrigidity and is configured and arranged to decrease the elasticity ofthe outer wall predominantly via the structural rigidity of a portion ofthe shape-memory alloy in the base member that extends between the firstand second ends and into which the tissue is grown.
 28. The cuff as inclaim 27, wherein the shape-memory alloy is configured and arranged todecrease the elasticity of the outer wall without interaction betweenthe base member and any other tissue in a patient in which the tubularbody organ resides.
 29. The cuff as in claim 1, wherein the shape-memoryalloy exhibits an internal structural rigidity that restricts expansionof muscle in the outer wall, thereby increasing a force required to openthe tubular body organ, while allowing the tubular body organ to moveindependently from other tissue in a patient in which the tubular bodyorgan resides.
 30. A method for imparting strength and compression to asoft tissue tubular anatomical organ comprising the steps of: (a)providing a cuff having a flexible base member of a material permittingtissue in-growth and with first and second ends, the cuff including ashape-memory alloy and being of a length between the first and secondends adapted to only partially surround a tubular organ over an arcgreater than 180° and less than about 310°; (b) providing a C-shapedclip of a resilient, bio-degradable material dimensioned to partiallysurround the tubular organ; and (c) securing the cuff to the tubularorgan with said clip such that the cuff is held in contact with an outerwall of the tubular organ for at least a time for allowing said tissuein-growth to take place.
 31. The method of claim 30 wherein the C-shapedclip is assembled to the cuff prior to step (c), and securing the cuffincludes securing the cuff with first and second ends thereof terminatedon the outer wall and utilizing the shape-memory alloy within the cuffand tissue in-growth to impart structural rigidity between the first andsecond ends sufficient to passively limit flow of material through alumen of the tubular organ.